To Compare the Effect of Intratracheal Administration of Surfactant vs. Surfactant/Budesonide on the Incidence of Bronchopulmonary Dysplasia in Preterm Infants Less Than 34 Weeks of Gestation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 336
- 主要终点
- Number of Participants With Treatment-Related Adverse Events
研究概览
简要总结
Objectiv: To compare the effect of intratracheal administration of surfactant vs. surfactant/budesonide on the incidence of bronchopulmonary dysplasia in preterm infants less than 34 weeks of gestation.
Material and methods: Study design: Double-blind randomized controlled clinical trial.Inclusion criteria: Newborns under 34 weeks of gestation with a diagnosis of Respiratory Distress Syndrome requiring administration of surfactant, invasive and/or non-invasive ventilatory support admitted to the Neonatal Intensive Care Unit service and pathological nursery. Procedure: 328 patients will be included from Group A: 164 patients, from Group B: 164 patients who meet the selection criteria within the first 4 hours of hospital stay, after the authorization of the parents or guardian signing the informed consent. According to the assigned group, the preparation of surfactant or surfactant/budesonide in the syringe will be carried out, prior to performing the tracheal cannulation procedure. Group A will be given surfactant (beractant, lung phospholipids of bovine origin. Injectable suspension 1ml contains 25mg) at a dose of 100mg/kg or 4ml/kg and budesonide (budesonide, nebulized suspension 2ml contains 0.500mg) at a dose of 0.250 mg/kg or 1 ml/kg. Group B will receive surfactant alone (beractant, lung phospholipids of bovine origin. Injectable suspension 1ml contains 25mg) administered at a dose of 100mg/kg or 4ml/kg. Subsequently, follow-up will be carried out at 12 hours to assess the administration of the second dose of surfactant, type of mechanical ventilation, inspired fraction of oxygen (Fi02), arterial pressure of oxygen (PaO2), partial pressure of carbon dioxide (PaCO2 ), mean airway pressure (PMVA), oxygen index (IO), oxygen saturation by pulse oximetry, weekly follow-up of the patient will continue for 28 days, evaluating the same parameters to make a diagnosis of bronchopulmonary dysplasia and finally at 36 postmenstrual weeks of gestation in those under 32 SDG or at discharge and at 56 postmenstrual days of life in those over 32 SDG or at discharge, allowing the severity of the disease to be determined.Sample size: The study includes an intervention group (surfactant/budesonide group) and a control group (surfactant only group), each with 164 patients, for a total of 328 patients.
Statistical analysis: The Chi-Square statistician will be used with a precision requirement of 95%, where p<=0.05. The risk measurement will be with RR (RR) and its 95% confidence interval (CI). NICSS 2007 statistical package will be used.
Ethical aspects: This study must have an authorization signature through informed consent.
详细描述
MATERIAL AND METHODS STUDY DESIGN Clinical, controlled, randomized, double-blind trial.
PLACE WHERE THE STUDY WILL BE DEVELOPED The study will be carried out in the High Specialty Medical Unit No. 48 of the Mexican Institute of Social Security of the CMN of Bajío León Guanajuato, in the Neonatal Intensive Care Unit (NICU) and pathological nursery service.
Location: Av. Mexico and Insurgentes S/N Col. Los Paraisos, CP 37220
DURATION OF THE STUDY Once authorized by the CNIC, the study will be carried out until the indicated sample is completed.
SOURCE OF INFORMATION Clinical records of all patients who enter the study in the NICU and pathological nursery service
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 26 Weeks 至 34 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Preterm newborn with clinical and radiographic data of respiratory distress syndrome requiring administration of surfactant.
- •Newborn both sexes. Preterm newborn requiring invasive and/or non-invasive ventilatory support. Preterm infant who has and does not have antenatal exposure to steroids.
排除标准
- •Patient with major congenital malformations, term newborn
- •Elimination criteria: Patient whose parents withdraw their consent.
结局指标
主要结局
Number of Participants With Treatment-Related Adverse Events
时间窗: the fisrt 48 hours, util the week of extrauterine will be monitored
evaluate the adverse events that occur. Budesonide: headache, stomach pain, hyperglycemia, electrolyte disturbances. Surfactant: bradycardia, hypotension, endotracheal tube obstruction, desaturation, patent ductus arteriosus, pulmonary hemorrhage
次要结局
- Assess the indicence of broncopulmonary displasia(first 28 days of extrauterine life our 36 postmenstrual weeks of gestation)
研究者
Guadalupe Gómez Rodríguez
principal investigator
Instituto Mexicano del Seguro Social